Vesalio’s NeVa VS Device Launched in the United States

February 23, 2023—Vesalio announced the successful initial use of its NeVa VS device in the United States for the treatment of postaneurysmal subarachnoid hemorrhage (aSAH) cerebral vasospasm. The company advised it is building a United States sales team in conjunction with the product launch.

In September 2022, the company announced FDA approval under a humanitarian device exemption for the commercialization of the NeVa VS retrievable nitinol stent to treat cerebral vasospasm after aSAH. Vesalio noted that vasospasm is the most common complication of aSAH and is the main cause of delayed morbidity and mortality.

“We are excited to be the first center to use the NeVa VS device in the United States,” commented Rishi Gupta, MD, in the company’s press release.

Dr. Gupta, who is Codirector of the Neurosciences Service Line and Director of Cerebrovascular Care at WellStar Health System in Marietta, Georgia, continued, “We have used the device in four patients thus far and have not had to return any of them to the cath lab for further treatment. The NeVa VS device is a valuable tool for the management of post-aSAH vasospasm.”

According to the company the NeVa VS device features smooth and continuous architecture, the operator-friendly deliverability of a stent retriever, and enhanced outward radial force to dilate critically narrowed vessels. The device provides rapid and durable vasospasm resolution and has been determined safe by the VITAL trial, which reported 93.2% of treated vessels required no retreatment.

In August 2022, Dr. Gupta et al published the primary results from the VITAL trial in Journal of NeuroInterventional Surgery (2022;14:815-819).